SCAMP Nutrition Study V1.0

• Research type

  Research Study

• Full title

  Standardised, Concentrated, Additional Macronutrients, Parenteral (SCAMP) nutrition in very preterm infants: a phase IV randomised controlled study of macronutrient intake, growth and implications for other aspects of neonatal care.

• IRAS ID

  14865

• Sponsor organisation

  Liverpool Women's Hospital NHS Foundation Trust

• Eudract number

  2008-008899-14

• ISRCTN Number

  76597892

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Very premature infants (born <29 weeks gestation) frequently demonstrate poor growth in the first weeks after birth (early postnatal growth failure). This affects all aspects of growth including head growth (an indirect measure of brain growth) and has long term implications for growth and neurodevelopment. Very preterm infants are unable to fully digest milk feed for several weeks, so intravenous feeding with neonatal parenteral nutrition (NPN) is required until full milk feeds are achieved. However, postnatal growth failure is still commonplace despite routine use of NPN. This is partly because optimal NPN macronutrient (protein, fat and carbohydrate) content has not been established. The practicalities of administering nutritionally adequate amounts of NPN in very sick preterm infants with compleflud, biochemical and pharmacological requirements is also a major problem. We have developed a novel standardised concentrated NPN (scNPN)formulation that, in conjunction with a system of standardised electrolyte infusions (the scNPN regimen) overcomes the inefficiencies in PN administration associated with conventional individually prescribed NPN (iNPN) regimens. We have shown that in very preterm infants scNPN improves protein intake by 20% when compared to a nutritionally identical iNPN. The proposed 2-year single centre study will randomise very preterm infants to receive scNPN (controls) or scNPNmax (intervention group). The scNPNmax regimen contains 30% more macronutrients but is otherwise identical to scNPN. Growth and nutritional intake in the first 28 days of life will be compared between the groups with head growth at 28 days as the primary outcome because of its relationship with early postnatal growth failure and neurodevelopmental outcome. Results of routine biochemical, metabolic, infection and line complication monitoring will also be compared between the groups. Longer term outcomes including growth at 36 weeks gestation, important complications of prematurity and neurodevelopment at 18 months corrected gestational age will also be compared.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  09/H1008/91

• Date of REC Opinion

  25 Jun 2009

• REC opinion

  Further Information Favourable Opinion